Development Safety Update Report (DSUR) — GLPI-103
| Field | Value |
|---|---|
| Document ID | DSUR-001 |
| Version | 1.0 |
| Status | Final (portfolio) |
| DSUR reporting interval | Development International Birth Date (DIBD) + 12 months [MOCK] |
| Compound | GLPI-103 (GLP-1 / Apelin [APJ] receptor dual agonist) |
| Sponsor | Virtual Biopharma Inc. |
| Standard(s) | ICH E2F · E2A · E6(R3) · CIOMS |
| Confidentiality | Confidential |
[MOCK — deep-knowledge assumption]Annual Development Safety Update Report covering the GLPI-103 clinical development program. Pivotal Phase 3 figures trace to CSR-301 (outputs/); early-phase content is illustrative.
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-30 | Pharmacovigilance | Initial DSUR (annual) |
1. Introduction
This DSUR presents a comprehensive, thoughtful annual review and evaluation of safety information for GLPI-103 collected during the reporting period across the development program, prepared per ICH E2F. GLPI-103 is an investigational dual GLP-1/APJ receptor agonist in development for type 2 diabetes mellitus (T2DM).
2. Worldwide Marketing Approval Status
GLPI-103 is investigational and not approved in any country; it is under clinical development under IND (US), CTA/IMPD (EU), and IND (KR) [MOCK].
3. Actions Taken for Safety Reasons
No clinical-trial suspensions, terminations, protocol modifications for safety, dosing changes, or restrictions were taken during the reporting period. Routine titration/dose-modification provisions for gastrointestinal tolerability operated as designed (PROT-301 §6).
4. Changes to Reference Safety Information (RSI)
The Investigator's Brochure RSI (IB-001 §7) was reviewed; the listed expected events (gastrointestinal events, injection-site reactions, hypoglycaemia with secretagogues) remain current. The class boxed-warning risks (thyroid C-cell/MTC, pancreatitis) continue to be managed by labeling and the RMP.
5. Inventory of Clinical Trials Ongoing/Completed in the Period
| Study | Phase | Status | N | Notes |
|---|---|---|---|---|
| GLPI103-101 (SAD) | 1 | Completed | 40 | Healthy volunteers |
| GLPI103-102 (MAD) | 1b | Completed | 40 | T2DM/prediabetes |
| GLPI103-201 (PoC) | 2 | Completed | 240 | Dose-finding |
| GLPI103-301 (pivotal) | 3 | Completed | 900 | Active-controlled |
6. Estimated Cumulative Exposure
Cumulative investigational exposure across the program is approximately 1,220 subjects (40+40+240+900), with up to 52 weeks of exposure in the pivotal study; healthy-volunteer and patient exposure are summarised separately [MOCK].
7. Data in Line Listings and Summary Tabulations
Serious adverse events and adverse events of special interest are presented as cumulative interval line listings and summary tabulations (appendices [MOCK]). In the pivotal study, 10 serious adverse events and 2 deaths were reported, none assessed as treatment-related (CSR-301 §12.5).
8. Significant Findings in the Period
- Efficacy-tolerability: dose-related gastrointestinal events (notably nausea, higher in the higher-exposure intravenous arm: 32.3% vs 21.4% comparator) — consistent with the GLP-1 class and managed by titration.
- Nonclinical: the 2-year rat carcinogenicity thyroid C-cell finding was investigated and characterised as rodent-specific/low human relevance (M4-2.3; QA-003 ISS-012); carried as a labeled class risk.
- No new or unexpected serious safety signal was identified during the period.
9. Late-Breaking Information
None.
10. Overall Safety Assessment and Conclusion
The cumulative safety profile of GLPI-103 remains consistent with the GLP-1 receptor agonist class and clinically manageable, with a gastrointestinal tolerability trade-off in the higher-exposure formulation addressed by titration, infrequent hypoglycaemia, no hepatotoxicity signal (eDISH; no Hy's-law cases), and class risks (MTC, pancreatitis) managed by labeling and the RMP. The benefit-risk for continued development and the marketing application remains favourable (M2.5.6). No changes to the RSI or risk-minimization measures are warranted at this time.